Events

Recall of ACUVUE OASYS FOR PRESBYOPIA BRAND CONTACT LENSES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON VISION CARE INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28740
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The company is initiating this voluntary recall as a precautionary measure following an internal quality review in which they discovered potential for a limited number of individual contact lenses to be slightly out-of-specifications for distance power.

Device

ACUVUE OASYS FOR PRESBYOPIA BRAND CONTACT LENSES
  • Model / Serial
    Model Catalog: OASYS FOR PRESBYOPIA (Lot serial: LOT #B00F7QK)
  • Product Description
    ACUVUE OASYS BRAND CONTACT LENSES FOR PRESBYOPIA WITH HYDRACLEAR PLUS
  • Manufacturer
    JOHNSON & JOHNSON VISION CARE INC.

Manufacturer

JOHNSON & JOHNSON VISION CARE INC.
  • Manufacturer Address
    JACKSONVILLE
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC